InSite HER-2 Detection Kit — Class II medical device recall Z-2113-2014
Terminated recall by Biogenex Laboratories, Inc., reported 2014-07-30. Product was distributed without 510(k) approval.
| Recall number | Z-2113-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biogenex Laboratories, Inc., Fremont, CA, United States |
| Recall initiated | 2014-07-01 |
| Classified | 2014-07-24 |
| Reported by FDA | 2014-07-30 |
| Terminated | 2014-07-24 |
| Countries outside the US | BR, EC |
| Quantity | 4 kits |
| Lot numbers | RD4710111, RD4710411, RD4711013 |
| Model numbers | RD471-60K |
| Expiration dates | 2012-01-20, 2012-04-20, 2014-10-20 |
Product
InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use.
Reason for recall
Product was distributed without 510(k) approval.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2113-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.